News & Analysis as of

Healthcare Scientific Research

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Manatt, Phelps & Phillips, LLP

TRIALS AND TRIBULATIONS: How to Remove Barriers Blocking Cancer Patients From Clinical Trials and Advance the Next Generation of...

EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more

Vicente LLP

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

Vicente LLP on

On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...more

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Epstein Becker & Green

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

Vicente LLP

A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

Vicente LLP on

As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. Groups Seek Substantive Revisions to HHS Misconduct Regs, Investigations:...

Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 11. In This Month’s E-News: November 2022

NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more

Manatt, Phelps & Phillips, LLP

PCORI Releases Draft Research Priorities for Public Comment

On January 6, 2022, the Patient-Centered Outcomes Research Institute (PCORI) released its Proposed Research Agenda, linked to its newly adopted National Priorities for Health that was developed during a comprehensive...more

McDermott Will & Emery

Blazing New Trails in Health Care and Technology Innovation Ventures

McDermott Will & Emery on

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and...more

Robinson & Cole LLP

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

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The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

King & Spalding

Also In The News - Health Headlines - October 2015 #2

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HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

Carlton Fields

Expect Focus – International, Summer 2015

Carlton Fields on

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Carlton Fields

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

Carlton Fields on

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Rare Genomics Institute Announces Crowdfunding Initiative for Rare Diseases

Earlier this month, Rare Genomics Institute, an international non-profit that makes cutting edge research technologies of genome sequencing, physicians and scientists around the world accessible to rare disease patients,...more

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